Actively Recruiting
DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
Led by Post Graduate Institute of Medical Education and Research, Chandigarh · Updated on 2026-05-14
400
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. This proposed double-blind placebo controlled randomized controlled trial incorporates recent advances in management of heart failure and portal hypertension using the SGLT-2 inhibitor i.e. EMPAGLIFLOZIN. The drug has been found to be useful in large trials on heart failure with preserved ejection fraction in the general population with improvement in MASLD progression, with improvement in body weight and hepatic steatosis but no change in liver fibrosis. 2. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been shown to reduce the development and progression of heart failure in patients with type 2 diabetes and in those with heart failure and a reduced and preserved ejection fraction. In patients with cirrhosis safety of empagliflozin in a dose of 10 mg has been demonstrated. 3. Prevention of decompensation related events in cirrhosis is the key endpoint of any liver-directed therapy as the median survival in the compensated state exceeds 10 years but median survival in the decompensated state approximates 1.5 years. Previous data has demonstrated the risk of hepatic decompensation acute kidney injury and poor survival in patients with cirrhosis and heart failure with preserved ejection fraction (HFpEF) i.e. LVDD a large subset of whom meet criteria for CCM.
CONDITIONS
Official Title
DICE Study- Diastolic Improvement With Carvedilol & Empagliflozin in Patients With Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years
- Diagnosis of cirrhosis confirmed by histology or clinical, laboratory, and ultrasound findings
- Presence of left ventricular diastolic dysfunction with ejection fraction greater than 50% confirmed by 2D echocardiography with tissue Doppler imaging
- Written informed consent provided
You will not qualify if you...
- Age over 65 years
- Serum creatinine greater than 2 mg/dl
- History of urinary tract or genital infections within the last 3 months
- Treatment with statins within one month prior to the study
- Advanced cirrhosis with MELD score greater than 20
- Coronary artery disease
- Sick sinus syndrome or presence of pacemaker
- Valvular heart disease
- Cardiac rhythm disorders
- Peripartum cardiomyopathy
- Portopulmonary hypertension or hepatopulmonary syndrome
- Prior transjugular intrahepatic portosystemic shunt (TIPS) insertion
- Hepatocellular carcinoma
- Pregnancy or breastfeeding
- HIV infection or receiving retroviral therapy
- Anemia with hemoglobin less than 8 gm/dl in females or less than 9 gm/dl in males
- Acute variceal bleeding within the last 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
PGIMER Chandigarh
Chandigarh, India, 160012
Actively Recruiting
Research Team
M
Madhumita Premkumar, MD DM
CONTACT
M
Madumita Premkumar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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